Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia

Mansoura University1 site in 1 country95 target enrollmentJuly 2008

ConditionsMenorrhagia

InterventionsNuvaRing Norethisterone Acetate tablets - 5mg

DrugsNuvaRing Norethisterone Acetate tablets - 5mg

Overview

Phase: Not Applicable
Intervention: NuvaRing
Conditions: Menorrhagia
Sponsor: Mansoura University
Enrollment: 95
Locations: 1
Primary Endpoint: Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

September 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Mansoura University

Eligibility Criteria

Inclusion Criteria

•Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception

Exclusion Criteria

•Menorrhagia of endocrine or systemic origin
•other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.

Arms & Interventions

NuvaRing

For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.

Intervention: NuvaRing

Norethisterone Acetate

Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment

Intervention: Norethisterone Acetate tablets - 5mg